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This role is accountable for defining the vision, operating model, and multi-year strategy for internal QC to support Genmab’s evolving pipeline and transition to a fully integrated, commercial-stage biotechnology company. The role will shape future QC
Lead, motivate and mentor your team to maximize their effectiveness by clearly communicating task details and goals to your team members, allowing them to work effectively. Foster a positive progressive culture within the lab that focuses on EED&I
In this role, you will oversee complex analytical projects, drive method development and validation activities, and ensure the highest standards of data integrity and regulatory compliance. You will collaborate closely with cross-functional partners -
The role assures that project output meets combination product regulatory requirements. This position assists in the development and implementation of site/Global QMS GMP policies and procedures. Additional responsibilities will ensure departmental
Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs. Act as QA contact for specific projects